Reprinted with permission from www.fdaweb.com
David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with LASIK. The announcement came from his new company Waltham, MA-based Avedro Inc., which Muller formed with venture capital backing in 2007 after Summit was acquired by Alcon.
The new NDA seeks an indication for the treatment of keratoconus (a naturally occurring disease in which the cornea distends in a cone shape) and corneal ectasia following refractive surgery (LASIK). Morris Waxler, the CDRH branch chief who led the approval of Muller’s device in 1996 and others like it, is now aggressively seeking the removal of their LASIK indication based on a higher permanent injury rate from the LASIK procedure than disclosed by the sponsors in their data submissions.
Avedro’s news release quoted Cornea and Laser Eye Institute medical monitor and director Peter Hersh as saying that the “ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients’ visual function over time.”
Corneal collagen cross-linking with riboflavin and ultraviolet light is described by the National Keratoconus Foundation as a process that increases natural collagen crosslinks in the cornea, thus strengthening it and preventing it from further bulging out. The treatment’s possible extension to treat post-LASIK ectasia was recognized by FDA last year as deserving of orphan drug designation, offering seven years market exclusivity. Avedro’s news release said the VibeX/KXL System for corneal collagen cross-linking received the European CE Mark in 2010 and has been commercially available internationally since then.
Watch video of an American Investigator report concerning David Muller, Summit Technology, and the scandal surrounding FDA leak of competitor’s, VISX Inc., documents. Watch
Read Jim Dickinson’s March 1999 article on the 1995 VISX Inc. document leak to rival Summit Technology’s then-President, David Muller: [Capitol] Hill closes file on device secrets leak: ex-reviewer did it. Read article